At a glance
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A Phase I Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating OZ439 mesylate 800mg Powder in Bottle for Oral Suspension, OZ439 mesylate 400mg Prototype Solution Formula 1, and 2 other interventions for Healthy Volunteers. Completed, enrolled 52 participants across 1 site.
Detailed Summary
This study is designed to assess prototype formulations compared to the aqueous dispersion of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that observed when given after food. This will improve the utility of OZ439 in the field as well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very important for an antimalarial drug product destined for use in developing counties.
Study Details
Timeline
Interventions
OZ439 800 mg (as free base) as powder in a bottle for reconstitution in a suspension prior to oral administration
OZ439 400 mg (as free base) as a prototype solution formulation 1
OZ439 800 mg (as free base) as a prototype solution formulation 1
OZ439 800 mg (as free base) as a prototype solution formulation 2